Trial · NCT04692155
Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL)
NCT04692155, Phase 1, Phase 2, Terminated, University of Alabama at Birmingham; results first posted 2023-09-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL). Trials, record NCT04692155. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04692155
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL)
- NCT number
- NCT04692155
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Mantle Cell Lymphoma
- Interventions
- Ublituximab, Umbralisib
- First posted
- 2020-12-31
- Last updated
- 2023-09-28
- Results first posted
- 2023-09-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Complete Remission at the End of Induction Treatment | 10 months | In the proposed study, the primary endpoint is to estimate the biological response rate of the combination of Umbralisib at dose 800 mg with Ublituximab (900mg)-CHOP, but a phase Ib portion with dose de-escalation at two does level (800 and 600 mg) will be built in to further confirm its safety and tolerability. Rate of complete remission at the end of induction treatment (U2-CHOP X 6 cycles) per PET/CT assessment criteria for Lymphoma (Cheson et al, 2014).Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Progression Free Survival (PFS) | Baseline through 3 years | To determine the efficacy of U2-CHOP in terms of PFS in patients with untreated MCL after induction phase (6 cycles of U2-CHOP) by PET/CT response assessment criteria by Cheson 2014 |
| Secondary | Overall Survival (OS) | Baseline through 3 years | To determine the efficacy of U2-CHOP in terms of OS in patients with untreated MCL after induction phase (6 cycles of U2-CHOP) by PET/CT response assessment criteria by Cheson 2014 |
| Secondary | Rate of Overall Response Rate (Complete Response CR+ Partial Response PR) | Baseline through 3 years | To determine the efficacy of U2-CHOP in terms of Overall Response rates (ORR) in patients with untreated MCL after induction phase (6 cycles of U2-CHOP) by PET/CT response assessment criteria by Cheson 2014. |
| Secondary | Rate of Disease Control Rate (CR+PR+SD) | Baseline through 3 years | To determine the efficacy of U2-CHOP in terms of Rate of disease control rate in patients with untreated MCL after induction phase (6 cycles of U2-CHOP) by PET/CT response assessment criteria by Cheson 2014 |
| Secondary | Rate of Minimal Residual Disease MRD Negativity at the End of Induction Treatment | Baseline through 2 years | MRD status is a future exploratory endpoint for this trial. Peripheral blood samples are required at the end of induction treatment |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Complete Remission at the End of Induction Treatment | 10 months | The patient died because of COVID infection. Not related to the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | Baseline through 3 years | The patient died because of COVID infection. Not related to the study drug. No data was collected. | ||
| SECONDARY | Overall Survival (OS) | Baseline through 3 years | The patient died because of COVID infection. Not related to the study drug. No data was collected | ||
| SECONDARY | Rate of Overall Response Rate (Complete Response CR+ Partial Response PR) | Baseline through 3 years | The patient died because of COVID infection. Not related to the study drug. No data was collected | ||
| SECONDARY | Rate of Disease Control Rate (CR+PR+SD) | Baseline through 3 years | The patient died because of COVID infection. Not related to the study drug. No data was collected | ||
| SECONDARY | Rate of Minimal Residual Disease MRD Negativity at the End of Induction Treatment | Baseline through 2 years | The patient died because of COVID infection. Not related to the study drug. No data was collected |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Complete Remission at the End of Induction Treatment | Phase 1b and Phase 2 | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1b and Phase 2 | 1 | |
| Overall Study | COMPLETED | Phase 1b and Phase 2 | 0 | |
| Overall Study | NOT COMPLETED | Phase 1b and Phase 2 | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b and Phase 2 | 1 | 1 |
| Total, other adverse events | Phase 1b and Phase 2 | 0 | 1 |
| Total, serious adverse events | Phase 1b and Phase 2 | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04692155
GET https://conductscience.org/api/trials/v1/NCT04692155/registered